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The investigators propose to use a weight-based regimen consisting of basal-bolus insulin and preprandial rapid-acting insulin and to test its efficacy and safety in controlling blood glucose in hospitalized patients with type 2 diabetes.
Patients with type 2 diabetes are randomly assigned by computer-generated block randomization to receive either weight-based or glucose level-based titration regimen. All antidiabetic drugs are discontinued on admission.
Starting dose:
Total daily insulin is 0.4U/kg. Half is given as glargine and the remainder as aspart which is divided into three equal parts used for three pre-meal boluses.
Titration:
Weight-based insulin titration regimen:
Glargine titration: 0.1U/kg per day when fasting blood glucose (FBG) is over 8.0 mmol/L.
Aspart titration: total dose 0.1U/kg per day when next pre-meal blood glucose (BG) is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses.
Glucose level- based titration regimen:
Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L.
Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-based | Experimental | Weight-based insulin insulin titration regimen |
|
| Glucose level-based | Placebo Comparator | Glucose level-based insulin titration regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight-based | Other | Glargine titration: 0.1U/kg per day when FBG is over 8.0 mmol/L. Aspart titration: total dose 0.1U/kg per day when next pre-meal BG is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses |
| Measure | Description | Time Frame |
|---|---|---|
| Duration | Duration to achieve BG targets, including three pre-meal BG and bedtime BG | at discharge, an average of 9 days |
| Doses | Doses of insulin glargine and insulin aspart when the BG targets are achieved | at discharge, an average of 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia | Incidence of hypoglycemia | at discharge, an average of 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Other adverse effects except hypoglycemia | at discharge, an average of 9 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodan Zhang, MD | Contact | 86-20-34152032 | sysuzhangxd@163.com | |
| Wangen Li, MD | Contact | 86-20-34152032 | liwg660@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wangen Li, MD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32933950 | Derived | Zhang X, Zhang T, Xiang G, Wang W, Li Y, Du T, Zhao Y, Mosha SS, Li W. Comparison of weight-based insulin titration (WIT) and glucose-based insulin titration using basal-bolus algorithm in hospitalized patients with type 2 diabetes: a multicenter, randomized, clinical study. BMJ Open Diabetes Res Care. 2020 Sep;8(1):e001261. doi: 10.1136/bmjdrc-2020-001261. |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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randomised controlled trial
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| Glucose level-based | Other | Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L. Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L. |
|
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |